Browsing by Author "Nabukenya, Sylvia"

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    Experiences and practices of key research team members in obtaining informed consent for pharmacogenetic research among people living with HIV: a qualitative study
    (Research Ethics, 2022) Ochieng, Joseph; Kaawa-Mafigiri, David; Munabi, Ian; Nakigudde, Janet; Nabukenya, Sylvia; Nakwagala, Frederick N.; Barugahare, John; Kwagala, Betty; Ibingira, Charles; Twimwijukye, Adelline; Sewankambo, Nelson; Mwaka Sabakaki, Erisa
    This study aimed to explore experiences and practices of key research team members in obtaining informed consent for pharmacogenetics research and to identify the approaches used for enhancing understanding during the consenting process. Data collection involved 15 qualitative, in-depth interviews with key researchers who were involved in obtaining informed consent from HIV infected individuals in Uganda for participation in pharmacogenetic clinical trials. The study explored two prominent themes: approaches used to convey information and enhance research participants’ understanding and challenges faced during the consenting process. Several barriers and facilitators for obtaining consent were identified. Innovative and potentially effective consenting strategies were identified in this study that should be studied and independently verified.
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    Researchers experience of using the regulatory affairs information system (RAIS) in strengthening research compliance in a large research program; A case study of the Infectious Diseases Institute(IDI) in Uganda
    (JAMIA open, 2022) Nabukenya, Sylvia; Okoboi, Stephen; Nakate, Vivian; Twimukye, Adelline; Opio, Bruce; Castelnuovo, Barbara
    The aim of this study was to explore researchers’ experience of using the regulatory affairs information system (RAIS) in strengthening research compliance to national ethics guidelines through tracking ethics and regulatory approvals for research projects at the Infectious Diseases Institute. We conducted a cross-sectional study using purposive sampling of 50 participants who were principal investigators (PI) and study coordinators (SC) of active projects between November 2019 and January 2020. Only 36 of them responded to the survey. We also conducted 12 key informant interviews among PI, SC, and research management at the Institute. We used STATA 13 to analyze responses to the survey. The interviews lasted between 20 and 30 min. We used NVivo 10 software to manage the transcripts and generation of themes. Majority 19 (52.8%) of those who participated in the survey were study coordinators, 19 (52.8%) had participated in more than 5 research studies, 28 (90.3%) had ever received a notification from the RAIS and 26 (92.9%) submitted requests for renewal of their studies approvals to Ethics committees and regulatory bodies 4 weeks prior to expiration dates. The study also examined participants’ general understanding of the regulatory requirements and all were aware that RECs and NDA grant approval for a period of 1 year, and 35 (97.2%) that UNCST grants approval for the duration of the study. Three prominent themes; researchers’ experiences, benefits, and shortcomings of RAIS were generated from the key informant interviews. Having experience in research coupled with a novel automated system provides a platform for a better understanding of research regulatory requirements, hence compliance to the national guidelines. Our case study demonstrates that supporting researchers and research institutions in low resource settings with an automated system in tracking expiration dates for research approvals can facilitate compliance to national ethics guidelines.